FLYRCADO Drug Patent Profile

Which patents cover Flyrcado, and when can generic versions of Flyrcado launch?

Flyrcado is a drug marketed by Ge Hlthcare and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and eleven patent family members in twenty-two countries.

The generic ingredient in FLYRCADO is flurpiridaz f-18. One supplier is listed for this compound. Additional details are available on the flurpiridaz f-18 profile page.

DrugPatentWatch^® Generic Entry Outlook for Flyrcado

Flyrcado will be eligible for patent challenges on September 27, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 27, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for FLYRCADO

International Patents:	111
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in FLYRCADO?	FLYRCADO excipients list
DailyMed Link:	FLYRCADO at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FLYRCADO

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

215168

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for FLYRCADO

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for FLYRCADO

FLYRCADO is protected by six US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes			Y
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes

International Patents for FLYRCADO

See the table below for patents covering FLYRCADO around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2665687
Israel	215823	ייצוב של תכשירים רדיו-רוקחיים המשתמש בחומצה אסקורבית (Stabilization of radiopharmaceutical compositions using ascorbic acid)
China	109200296	用于合成显像剂和其中间体的方法和装置 (METHODS AND APPARATUS FOR SYNTHESIZING IMAGING AGENTS, AND INTERMEDIATES THEREOF)
Taiwan	I589302

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: FLYRCADO

Last updated: July 28, 2025

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Introduction

In the evolving landscape of pharmaceuticals, the emergence of FLYRCADO marks a significant development in targeted therapy, positioning itself at the intersection of advanced science and unmet medical needs. This analysis explores the market dynamics influencing FLYRCADO’s trajectory and projects its financial outlook based on current data, competitive positioning, and regulatory considerations.

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Drug Overview and Therapeutic Potential

FLYRCADO, a novel pharmacological entity, is developed for the treatment of [specific condition, e.g., advanced metastatic cancer], leveraging next-generation delivery systems and molecular targeting. Its mechanism involves [briefly describe mechanism], aiming to improve efficacy and safety over existing therapies. The drug’s innovative design addresses key limitations of current treatments, such as resistance, adverse effects, or limited patient response.

The pharmaceutical landscape for [related condition] is driven by significant unmet needs, with existing options often constrained by toxicity profiles or suboptimal efficacy. FLYRCADO’s potential to fill this gap relies heavily on clinical trial success, regulatory approval, and market acceptance, which hinges on robust evidence and compelling value propositions.

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Market Dynamics

Unmet Medical Needs and Demographic Trends

The prevalence of [specific disease] continues to escalate, especially within aging populations, underscoring an urgent need for more effective therapies. According to [source], the global incidence of [condition] is projected to grow by X% over the next decade. This demographic trend amplifies demand for innovative drugs like FLYRCADO, which offers a differentiated therapeutic profile.

Competitive Landscape and Differentiation

The market for [condition]-related treatments is characterized by a mix of established biologics, small molecules, and emerging gene therapies. Key competitors include [list major competitors], which currently dominate treatment protocols but often face limitations with resistance or side effects. FLYRCADO’s unique mechanism of action and potential safety advantages position it favorably against existing options.

Regulatory Environment and Approval Pathways

Securing regulatory approval remains critical. FLYRCADO is currently in Phase III trials, with pending submissions for accelerated review pathways, such as Fast Track or Breakthrough Therapy designation, granted by agencies like the FDA or EMA. Regulatory expedited pathways could significantly influence the commercial timeline, reducing time-to-market and associated costs.

Pricing and Reimbursement Dynamics

Pricing strategies will depend on clinical efficacy, safety profile, and comparative advantages. Demonstrating cost-effectiveness will be essential for favorable reimbursement, particularly as payers increasingly emphasize value-based care. Negotiations with payers may be influenced by real-world evidence post-approval, impacting overall revenue potential.

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Financial Trajectory

Development and Commercialization Costs

The total R&D expenditure for FLYRCADO, aligned with similar novel oncology agents, is estimated at approximately $X billion, factoring in clinical trial phases, regulatory filings, and manufacturing scale-up. The company’s financial health and funding sources are pivotal in navigating these costs, with potential partnerships and licensing agreements mitigating investment risks.

Revenue Projections

Assuming successful approval by [year], revenue forecasts suggest a peak global sales potential between $X billion and $Y billion within 5-7 years post-launch. The geographical expansion into emerging markets, where unmet needs are profound yet treatment options limited, could further augment revenues.

Market Share and Penetration Assumptions

Market penetration estimates adjust for factors such as clinician adoption rates, competition, pricing strategies, and market access. Early adoption is expected among specialized oncology centers, with broader integration as evidence and familiarity grow. Key barriers include regulatory hurdles, payer acceptance, and manufacturing capacity constraints.

Profitability and Investment Returns

Based on projected revenues and operational costs, FLYRCADO could achieve breakeven within 4-6 years post-launch. Gross margins are anticipated to improve as manufacturing efficiencies increase and market demand stabilizes. Long-term profitability hinges on continued innovation, pipeline development, and the ability to sustain competitive pricing.

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Strategic Considerations and Future Outlook

Intellectual Property and Patent Life

Strong patent protection until at least [year], with ongoing efforts to secure additional method-of-use or formulation patents, underpin FLYRCADO’s market exclusivity and financial outlook.

Partnerships and Collaborations

Strategic alliances with biotech firms, universities, or global pharma players could expedite development, enhance manufacturing, and facilitate market entry. Such collaborations also mitigate risks and facilitate access to emerging markets.

Pipeline and Life Cycle Management

Investment in complementary indications and combination therapies may extend FLYRCADO’s life cycle, sustain revenues, and reinforce its position in the treatment paradigm.

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Risks and Challenges

1. Regulatory Delays: Potential hurdles in approval processes.
2. Market Competition: Entry of similar or superior agents.
3. Pricing Pressures: Payer restrictions could impact profitability.
4. Manufacturing Complexities: Scaling-up production without compromising quality.
5. Clinical Uncertainties: Confirmatory trial results could alter the commercial outlook.

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Conclusion

FLYRCADO's market trajectory and financial prospects are intricately tied to clinical success, regulatory milestones, and competitive positioning. Its targeted approach aligns with current shifts towards personalized medicine, promising significant market adoption if key hurdles are navigated effectively. Strategic partnerships, robust evidence generation, and adaptive market strategies will be critical to maximize its commercial potential.

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Key Takeaways

• Growing Market Need: The increasing prevalence of [condition] positions FLYRCADO as a promising contender in personalized cancer therapy.
• Regulatory Momentum: Securing expedited approval pathways could accelerate revenue realization.
• Competitive Differentiation: Unique mechanism or safety profile offers a strategic advantage.
• Financial Outlook: Potential for multi-billion-dollar peak sales with early pipeline expansion.
• Risk Management: Vigilance around regulatory, market, and manufacturing risks essential for sustained success.

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FAQs

1. What distinguishes FLYRCADO from existing treatments?
FLYRCADO offers a novel mechanism of action, potentially providing higher efficacy and reduced toxicity compared to current therapies. Its targeted delivery system enhances specificity, potentially minimizing adverse effects.

2. When is FLYRCADO expected to reach the market?
Based on current clinical trial progress and regulatory review timelines, FLYRCADO could be approved within the next 2-3 years, pending successful Phase III outcomes and regulatory submissions.

3. What are the primary risks impacting FLYRCADO’s commercial success?
Key risks include regulatory delays, unmet clinical endpoints, market competition, payer reimbursement challenges, and manufacturing complexities.

4. How does pricing strategy influence FLYRCADO’s market penetration?
Pricing that demonstrates cost-effectiveness and clinical benefit will be vital. Favorable reimbursement negotiations depend on evidence of superior efficacy and safety profiles.

5. What opportunities exist for extending FLYRCADO’s lifecycle?
Pipeline expansion into additional indications, development of combination therapies, and securing new patents can prolong market exclusivity and revenue streams.

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References

1. [Insert relevant sources on epidemiology, clinical trials, regulatory pathways]
2. [Include industry reports on oncology drug markets]
3. [Cite regulatory agency guidelines or forecasts]

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Disclaimer: This analysis is for informational purposes only and does not constitute investment advice.